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Completed Phase 3 Interventional Results available

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

ClinicalTrials.gov ID: NCT00709852

Public ClinicalTrials.gov record NCT00709852. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 3:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Crossover, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Study identification

NCT ID
NCT00709852
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
402 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2008
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009
Last update posted
Dec 29, 2014

2008 – 2009

United States locations

U.S. sites
24
U.S. states
17
U.S. cities
23
Facility City State ZIP Site status
West Alabama Research, Inc. Birmingham Alabama 35209
Achieve Clinical Research, LLC Tuscaloosa Alabama 35406
Los Gatos MRI Los Gatos California 95032
Hoag Memorial Hospital Presbyterian Newport Beach California 92658-6100
Redwood Regional Medical Group, Inc. Santa Rosa California 95403
University of Florida - Jacksonville Jacksonville Florida 32209
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois 60201
Atchison Hospital Atchison Kansas 66002
University of Maryland Hospital System Baltimore Maryland 21201
Johns Hopkins Hospital/Health System Baltimore Maryland 21287
Shields MRI - Brockton Brockton Massachusetts 02301
VA Boston Healthcare System-West Roxbury Division West Roxbury Massachusetts 02132
Washington University School of Medicine St Louis Missouri 63110
University of New Mexico School of Medicine Albuquerque New Mexico 87131
Kingston Neurological Associates, PC Kingston New York 12401
NYU Hospital for Joint Diseases New York New York 10003
Duke University Medical Center Durham North Carolina 27707
The Cleveland Clinic Cleveland Ohio 44195
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104
Allegheny General Hospital Pittsburgh Pennsylvania 15212
Rhode Island Hospital Providence Rhode Island 02903
Medical University of South Carolina Charleston South Carolina 29425
University of Washington Medical Center Seattle Washington 98195
Aurora Saint Luke's Medical Center Milwaukee Wisconsin 53215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00709852, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 29, 2014 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00709852 live on ClinicalTrials.gov.

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